Enhancing Connections: Helping the Mother With Breast Cancer Support Her Child

NCT ID: NCT00194571

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30
• Study Completion Date: 2007-05-31

Brief Summary

This is a 6-state randomized controlled trial (RCT) that uses a behavioral intervention to enhance parenting skills for school age children when a mother is recently diagnosed with early stage breast cancer. Efficacy analyses will include measures of the child's and mother's psychosocial adjustment, including enhanced parenting quality and skills related to the cancer.

Detailed Description

This is a Phase 3 randomized clinical trial of recently diagnosed mothers with local or regional breast cancer and their school age child. After baseline measures are taken, mothers are randomized into either intervention and control group. Intervention participants are given 5, 1-hour at home educational counseling sessions by a specially trained nurse. Control participants are mailed an educational booklet whose content focuses on supportive parenting behaviors that are part of the face to face sessions given to the experimental group.

The theoretical framework for the study derives from Bandura's Social Cognitive Theory, a contextual model of parenting, and stress and coping theory. Efficacy is evaluated through standardized valid and reliable questionnaires of psychosocial functioning in the mother (affect, mood, self-efficacy) and psychosocial functioning in the child (cognitive-emotional functioning, including behavioral problems, anxiety, depressed mood, and cancer-related concerns). Primary study hypotheses will be evaluated comparing pre-posttest measures of the intervention compared to controls at post-test and 1-year follow up.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Educational counseling intervention

This intervention involves 5 face to face educational counseling sessions with a specially trained patient educator; sessions are fully manualized and complemented by handouts given to the diagnosed parent.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Local or regional breast cancer recently diagnosed
• Able to read and write English
• Has one or more school age child(ren) living at home
• Married to a man or in a committed long-term intimate relationship with a male partner

Exclusion Criteria

• Non-English speaking
• Advanced stage breast cancer
• Not recently diagnosed
• Single mother

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Frances M. Lewis

Professor, Family and Child Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frances M Lewis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

Almulla HA, Lewis FM, Oxford ML. Development and Psychometric Evaluation of the Children's Illness-Related Concerns Scale. Nurs Res. 2023 Sep-Oct 01;72(5):E172-E179. doi: 10.1097/NNR.0000000000000670.

Reference Type: DERIVED

PMID: 37625187 (View on PubMed)

Other Identifiers

1R01CA078424-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16636-C

Identifier Type: -

Identifier Source: org_study_id